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A Two Part, Phase 1, Multicenter, Open-label Study of DKN-01 Given Intravenously. Part A: A Dose-Escalation Study in Patients With Multiple Myeloma or Advanced Solid Tumors. Part B: An Expansion Cohort in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)

Trial Information

A Two Part, Phase 1, Multicenter, Open-label Study of DKN-01 Given Intravenously. Part A: A Dose-Escalation Study in Patients With Multiple Myeloma or Advanced Solid Tumors. Part B: An Expansion Cohort in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)

Part A of this trial consists of 4 treatment arms of DKN-01. It is a dose escalation study in patients with multiple myeloma or advanced solid tumors. Patients must be refractory or intolerant to all standard/approved therapy(ies). At each dose level, 3 subjects will be treated. If none of the 3 subjects develop a dose limiting toxicity after a minimum of 4 weeks of treatment, subsequent dose escalation will proceed according to the same schedule. Part B consists of dose confirmation in patients with NSCLC. Patients must be refractory or intolerant to all standard/approved therapy(ies). Approximately 15 patients may be enrolled in Part B.

Inclusion Criteria:

- Part A Only: Patients with histological or cytological confirmed multiple myeloma or advanced solid tumors. For multiple myeloma, patients must have symptomatic myeloma as defined by the International Myeloma Working Group inclusive of measurable serum and/or urine monoclonal protein (M-protein) or for those patients without elevations they must have measurable increased concentrations of free light chains

- If receiving warfarin; INR ≤ 3.0 and no active bleeding (that is, no bleeding within 14 days prior to first dose of study therapy)

- For men and women of child-producing potential, the use of effective contraceptive methods during the study and for women 18 months following the last dose of study drug

- NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) during the study, and women must agree to use adequate contraception prior to study entry and for 18 months after their last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

- Serum calcium:

- For solid tumors only: within institutional normal limits

- Multiple myeloma: ≤ 11.5 milligrams per deciliter (mg/dL)

Exclusion Criteria:

- History of osteonecrosis of the hip or have evidence of structural bone abnormalities in the proximal femur on magnetic resonance imaging (MRI) scan that are considered clinically significant or may have an impact on the interpretation of the scan. Degenerative changes of the hip joint are not exclusionary

- Are unable to tolerate the confinement/noise of an MRI scanner or have any contraindication for MRI, including but not limited to the following:

- Cardiac pacemakers

- Prosthetic heart valves

- Metallic splinters in the eye

- Ferromagnetic hemostatic clips in the central nervous system or body hemostatic clips

- Have Fridericia-corrected QT interval (QTcF) greater than (>) 470 millisecond (msec) (female) or > 450 (male), or history of congenital long QT syndrome. Any ECG abnormality that in the opinion of the investigator would preclude safe participation in the study

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